Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
About the study
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Able to understand and comply with study procedures and give written informed consent
- Age ≥18 years
- NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
- Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
Meet all inclusion criteria outlined in clinical study protocol
EXCLUSION CRITERIA
Exclusion Criteria:
- Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
- Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
- Evidence of other forms of chronic liver disease as defined in clinical study protocol
Does not meet any other exclusion criteria outlined in clinical study protocol
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
NASH
Age (in years)
18+
Phase
Phase 2
Participants needed
300
Est. Completion Date
Jun 30, 2025
Treatment type
Interventional
Sponsor
Kowa Research Institute, Inc.
ClinicalTrials.gov identifier
NCT05327127
Study number
K-001-201
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